Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death (SMART-ICD)

Unity Health Toronto

Status: Terminated

Conditions: Ventricular Dysfunction; Coronary Heart Disease; Low Cardiac Output; Sudden Cardiac Death; Congestive Heart Failure

Treatments: Device: Implantable Cardioverter Defibrillator; Drug: Optimized medical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00524862

06368

Details and patient eligibility

About

Recent ACC/AHA/ESC guidelines recommend prophylactic ICD implantation in most patients with coronary heart disease and LVEF < 40%. Current Canadian guidelines recommend ICDs for primary prophylaxis in CAD patients with LVEF < 30% (Class I recommendation). There are very sparse data to recommend ICD implantation in patients with EF between 30 and 40 %. This study will randomize patients with CHD and an EF between 30 and 40% to ICD therapy vs. No ICD therapy. The primary outcome is mortality and the study is powered as a non-inferiority trial to test the hypothesis that mortality in patients with no ICD is not more than 1% greater (absolute yearly increase) than patients receiving an ICD.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• documented chronic coronary heart disease (prior MI and/or angiographically documented CAD), > 40 days post the most recent MI;
• LVEF < 40% (by MUGA) and NYHA functional class II or III at time of assessment OR LVEF ≤ 35 % (by MUGA) and NYHA functional class I, II or III at time of assessment
• Judged to have a reasonable expectation of survival with a good functional status for more than 1 year, as well as receiving optimum, guideline recommended therapy for coronary artery disease and heart failure (or demonstrated intolerance or contraindications to such therapy).
• Age ≥ 18 years; no upper age limitation.

Exclusion criteria

• Prior cardiac arrest, sustained VT or VF, or unexplained syncope.
• Attempted VT / VF induction at electrophysiological study.
• Need for a cardiac resynchronization therapy (CRT) device.
• Enrollment in another interventional trial.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,000 participants in 2 patient groups

1

Other group

Treatment:

Drug: Optimized medical therapy

2

Other group

Treatment:

Device: Implantable Cardioverter Defibrillator